Lawmakers go after Amgen and J&J Over Off-Label Sales of Anemia Drugs

Evelyn Pringle April 22, 2007

To increase profits, drugs used to treat anemia in patients covered by Medicare are being given at higher doses and for conditions not approved by the FDA, due to reimbursement policies adopted by the Centers for Medicare and Medicaid Services under the leadership of top officials appointed by the Big Pharma-friendly Bush Administration.

At a December 6, 2006 hearing of the House Ways and Means Committee, then chairman Bill Thomas (R-CA), told Leslie Norwalk, acting commissioner of the CMS, “we have a payment policy that perhaps is killing people; and we are using $2 billion, the highest price paid in a relatively narrow area for the use of the drug through the payment policy, that may in fact be doing that.”

Studies have shown that the massive off-label marketing of these drugs has definitely resulted in many deaths, but the question that remains is how many.

The drugs at issue include Aranesp, the brand name for darbepoetin, and Epogen and Procrit, the brand names for epoetin. Amgen manufactures all three drugs, but Ortho Biotech Products, a Johnson & Johnson subsidiary markets Procrit.

They are top money-makers for both companies. In 2006, ESA’s combined had sales of nearly $10 billion, and Aranesp and Epogen accounted for $6.63 billion, or 48% of Amgen’s total $14.3 billion revenue in 2006.

The drugs belong to a class known as Erythropoiesis Stimulating Agents (ESAs), which are man-made versions of a hormone normally produced in the kidneys to stimulate bone marrow cells to produce hemoglobin which is the main component of red blood cells.

The severity of anemia is determined by a patient’s hematocrit, the proportion of red blood cells in whole blood, which should remain at between 33% and 36%, according to the FDA. The labeling for ESAs specifies that patients should have a hemoglobin level no higher than 12 grams per deciliter of blood.

ESAs are approved only to treat anemia and reduce the need for blood transfusions in patients with chronic kidney failure undergoing dialysis, patients with cancer who are receiving chemotherapy, patients scheduled for major surgery, and HIV patients with anemia due to zidovudine therapy.

However, they are being administered off-label to kidney patients who are not receiving dialysis, cancer patients who are not undergoing chemotherapy and in doses that result in higher levels of hemoglobin than are approved by the FDA as safe and effective.

On March 9, 2007, the FDA announced that all ESAs must carry black box warnings on their labels about the increased risk for serious side effects, including death, and advised doctors that they should use the lowest dose necessary to avoid the need for blood transfusions caused by anemia.

Several recent reports have shown that dialysis centers are administering higher doses of ESAs which has resulted in an increased rate of stroke, heart attack and death in dialysis patients. The dosage received by the typical dialysis patient in the US has nearly tripled since the early 1990s, according to the November 16, 2006, New York Times.

A paper presented at the annual conference of the American Society of Nephrology[,] reported that 37% of patients at Davita clinics, the second largest provider of dialysis in the US, had hemoglobin levels higher than 14 grams at least one time in a 9-month period.

Dialysis patients in the US are dying at a higher rate due to this drugging-for-profit scheme. In Europe, where lower doses of ESAs are given, the Times reports that, about 15% of dialysis patients die each year compared to 22% in the US.

Dialysis centers are also boosting profits by administering the drugs intravenously instead of by injection. According to the Boston Globe on October 24, 2006, clinics would use 30% less ESAs, at a potential savings of $375 million each year, if ESAs were injected because the method require a lower dose and they stay in the system longer.

Critics blame the over-use on the financial incentives in Medicare reimbursement policies. Medicare covers medical care for patients with End Stage Renal Disease, and between 1998 and 2003, spending for ESRD patients increased nearly 50%. About $64,000 a year is spent for each dialysis patient, according to US Renal Data System.

Medicare guarantees dialysis centers a 6% profit for administering ESAs, and in April 2006, the CMS drew fire from Capitol Hill when it adopted a policy allowing payment for the administration of ESAs until hematocrits reached 39%.

The Ways and Means Committee chairman, Rep Thomas, sent a letter chastising Mark McClellan, the CMS Administer at the time, asking why CMS had not developed a policy to deal with the out-of-control dosing of patients at a higher levels. “I cannot understand why CMS would knowingly contradict FDA findings,” he wrote.

The CMS did not respond to the letter, so in November 2006, incoming chairman of the Committee, Rep Pete Stark (D-CA), and Rep Thomas sent a another letter to acting CMS Administrator Leslie Norwalk, describing the CMS policy as “a reimbursement incentive for providers to continue to increase doses” past the approved level.

Ms Norwalk did not respond to that letter either, but on December 6, 2006, Ms Norwalk and specific experts were called to testify at a Committee hearing due to “growing concern about unsafe and questionable treatment for Medicare’s coverage for kidney failure, also known as End Stage Renal Disease,” Rep Thomas said.

Through the current rules which endorse expanding reimbursement to allow hematocrit to be targeted to any level, Thomas said, CMS has implemented a policy harmful to its beneficiaries that will cost hundreds of millions of dollars in additional expenditures.

During the questioning of Ms Norwalk, it was revealed that the Monitoring Policy Group, created by the CMS, approved the higher hematocrit guidelines, and two-thirds of the members had financial ties to either Amgen, Johnson & Johnson or the dialysis clinics that profit by selling more of the drugs.

“Now what troubles me is that of the 24 members,” Rep Stark told Ms Norwalk, “18 of them disclosed financial associations with Amgen or Johnson & Johnson.”

It was also noted that the National Kidney Foundation guidelines had raised the hemoglobin limit to 13. However, a clue as to how that came about surfaced a few months later on March 21, 2007, when the New York Times reported that the president of the Foundation, Dr Allan Collins, was also the director of the Minneapolis-based Medical Research Foundation and in 2004, the year he was made president, Amgen underwrote more than $1.9 million worth of research and education programs led by Dr Collins, and paid him at least $25,800 in mostly consulting and speaking fees in 2005.

Dr Laura Pizzi, a professor at Jefferson Medical College, testified as lead author on a study in the November 2006, Dialysis and Transplantation journal, conducted to determine to what extent health care providers were adhering to clinical guidelines for patients receiving dialysis.

She said the study found significant overuse of the drugs, and although the researchers were not surprised to see that providers were not strictly adhering to the guidelines, they were surprised by the extent to which ESA use deviated from the recommendations.

When converting the increased use to dollar amounts based on Medicare reimbursement rates in 2005, Dr Pizzi said the population with a red blood cell count above industry guidelines had higher drug costs of $3,100 per patient each year.

“We estimate that CMS,” she told the panel, “could have reduced expenditures for these drugs by 36 percent if dialysis facilities adhered to the guidelines.”

If CMS spends $2 billion a year, she said, “it is reasonable to say that several hundred million dollars could have been saved if the providers followed the guidelines.”

Dr Noshi Ishak, a kidney specialist who owns a dialysis clinic in Laconia, NH addressed the huge profits of administering ESA’s intravenously instead of by injections.

He said he switched to administering the drugs by injection in 1998 and usage dropped by more than 20%, or equivalent “to $3,120 savings per patient per year for Medicare.”

The FDA’s Oncology Drugs Advisory Panel is scheduled to meet on May 10, 2007, to review the safety and effectiveness of ESAs, and lawmakers have ordered Amgen and J&J to cease all direct-to-consumer advertising and physician incentives until the FDA determines whether measures need to be taken to protect the public from these products.

Amgen and J&J Funnel Tax Dollars Through Kidney and Cancer Patients

Evelyn Pringle April 17, 2007

Medicare has provided coverage for all patients with End Stage Renal Disease since 1972, and according to the House Ways and Means Committee, the government pays for 93% of services provided to dialysis patients, at a cost of about $2 billion a year.

In 2005, the drugs darbepoetin and epoetin, commonly used by patients who must undergo dialysis, accounted for almost 20% of the $13 billion spent on the Medicare Part B drug plan, and total sales for these drugs worldwide topped $9 billion.

Amgen manufactures and markets darbepoetin as Aranesp, and epoetin is sold under the names Procrit and Epogen. But Procrit is distributed by Ortho Biotech Products, a Johnson & Johnson subsidiary. There are no generic versions of these medications.

The drugs are among the top sellers for both companies. Amgen’s Epogen and Aranesp combined sales were $6.6 billion in 2006, nearly half of the company’s total revenues. Johnson and Johnson’s revenues were $3.2 billion in 2006, making it the company’s second-biggest-selling drug, according to on March 21, 2007.

The drugs are man-made versions of erythropoietin, a hormone normally produced in the kidneys, and belong to a class of drugs known as Erythropoiesis Stimulating Agents. ESA’s are used to treat anemia in raising hemoglobin levels by increasing the number of red blood cells in the body. Anemia’s severity is monitored by a patient’s hematocrit, the proportion of red blood cells in whole blood, which should stay between 33% and 36%.

According to the FDA, ESAs are approved to treat anemia in patients with chronic kidney failure, patients with cancer whose anemia is caused by chemotherapy, patients scheduled for major surgery to reduce potential blood transfusions, and for the treatment of anemia due to zidovudine therapy in HIV patients.

But Aranesp, Epogen, and Procrit are being administered “off label” for uses and in doses not approved by the FDA. For instance, an Amgen vice president recently estimated that about 10% to 12% of Aranesp sales are for the unapproved use of treating “anemia of cancer” in patients who are not undergoing chemotherapy.

A recent company study conducted to support FDA approval for using the drug to treat “anemia of cancer” in patients with cancer in remission who were not undergoing chemotherapy, revealed that Aranesp actually increased the risk of death in these patients.

The February 2, 2007, “Cancer Letter ,” a newsletter for cancer professionals, warns, “If the findings of the recently reported study hold up, more than one in 10 Americans getting Aranesp without chemotherapy has no chance of benefiting from the agent and could be harmed or killed by it, experts say.”

The report estimated that up to 12% of the use of ESAs in the US was for this condition.

After reviewing the results of this study and several others, on March 9, 2007, the FDA announced that black box warnings would be added to the labels for all ESAs and recommended using the lowest possible dose to raise the hemoglobin concentration to the lowest level.

The FDA-approved labeling for the drugs says patients should have a hemoglobin level of 10-12 grams per deciliter of blood, and patients are considered to need treatment if their levels fall below 10 grams.

During a press briefing, Dr Richard Pazdur, director of the FDA’s Office of Oncology Drug Products at the Center for Drug Evaluation and Research, said the black box warning was being added based on the results of several recently reported clinical trials.

Dr Karen Weiss, deputy director of the Office of Oncology Drug Products, said the FDA became concerned after receiving the results from several trials evaluating the aggressive use of ESAs to raise hemoglobin levels higher than listed on their approved labels.

In the March 10, 2007 Wall Street Journal, Dr Weiss was quoted as saying, the “bulk of the data that has raised concerns” came when patients were given higher doses, whether they were experiencing anemia from kidney disease or cancer treatment.

The evidence shows that “this type of strategy is not beneficial and, in fact, has some evidence of harm,” she said.

On March 9, 2007, the FDA also issued a public health advisory based on the results of a number of studies and warned doctors treating patients with kidney disease or cancer not to push hemoglobin levels over 12 grams per deciliter of blood.

The FDA noted a higher chance of death and an increased rate of tumor growth in cancer patients with advanced head and neck cancer receiving radiation therapy and in patients with metastatic breast cancer receiving chemotherapy, when ESAs were given to maintain levels of more than 12.
There was also a higher rate of death reported, but no fewer blood transfusions, when ESAs were given to patients with cancer and anemia who were not receiving chemotherapy.

A higher chance of death and an increased number of blood clots, strokes, heart failure and heart attacks were found in patients with chronic kidney failure when ESAs were given to raise hemoglobin levels of more than 12.
The Advisory warned that a higher risk of blood clots was also reported in patients who were scheduled for major surgery and received ESAs.

The FDA pointed out that ESAs are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer, surgical patients and patients with HIV.

The drug makers have been using direct-to-consumer advertising to increase sales with cancer patients by claiming the drugs could restore energy and reduce fatigue in patients undergoing chemotherapy. But the FDA says there has never been any evidence to support claims that ESAs could increase energy or ease fatigue in patients undergoing cancer treatment.

In recent months, Congress has been investigating Medicare reimbursement policies that guarantee dialysis clinics a 6% profit for administering ESAs, since it became apparent that patients are being given higher doses than needed. Critics say any deal that allows for cost plus payments comes with a built-in incentive to provide unnecessary services.

On October 24, 2006, the Boston Globe reported that dialysis clinics are also increasing profits by administering ESAs intravenously instead of by injection, and about 95% of the patients receive the drugs intravenously.

Clinics could use 30% less, the Globe says, because when ESAs are injected they stay in the system longer and require a lower dose. A 2004 analysis found patients injected with the drugs were given 21% less, for a potential total savings of about $375 million.

The two clinic chains that dominate the dialysis industry are DaVita, with over 1,200 clinics, and Fresenius Medical Care, with about 1,500. According to the Globe, the clinics claim the intravenous method is more convenient because patients are already hooked up to IVs for dialysis.

Critics think differently. “The industry is incentivized to use intravenous because they make a profit margin on every unit they administer,” said Dr Peter Crooks, who oversees dialysis for 3,000 patients for Kaiser Permanente where most patients receive injections.

In an April 11, 2007 report, Bernstein Research estimates that dose volume in renal patients could fall as much as 25% if doctors abide by the new black box warning and insurers refuse to pay for the drugs in patients with hemoglobin levels over 12.

On November 17, 2006, the British journal Lancet reported that about half of all dialysis patients have hemoglobin levels above what the FDA considers safe, and about 20% of patients experience dangerously high levels, creating a risk for heart attack and stroke.

Cancer Industry Fights To Keep Obscene Profits – Part I

Evelyn Pringle January 2008

The cancer industry derives most of its profits from chemotherapy. Both the drug companies and the treatment providers profit from the chemotherapy drugs and the medications used to combat the side effects. The obscene profits made off chemotherapy override any incentive to find a cure or better treatments.

Doctors administer chemotherapy in their offices, buy the drugs at a lower cost than what insurance companies and public health care programs pay and pocket the difference.
This system provides an incentive to overuse chemotherapy and the most expensive medications.

A 2001 study by the National Institute of Health found that about a third of Medicare beneficiaries received chemotherapy in the last six months of their lives, even through their cancer was unresponsive to chemotherapy, which “strongly suggests overuse of chemotherapy at the end of life,” the report said.

A 2006 study in the Health Affairs journal entitled, “Does Reimbursement Influence Chemotherapy Treatment for Cancer Patients,” determined that reimbursement had a direct effect on which drugs doctors prescribed for cancer patients. For instance, the study found that a $1 increase in reimbursement resulted in the use of chemotherapy drugs that cost $23 more.

A survey by Dr Neil Love, entitled, “Patterns of Care,” found that for first-line chemotherapy of metastatic breast cancer, 84-88% of the academic center oncologists who did not derive profits from infusion chemotherapy prescribed an oral drug, only 13% prescribed infusion drugs and none prescribed the expensive, highly-remunerative drug docetaxel.

In contrast, community-based oncologists who did profit from infusion chemotherapy, prescribed an oral dose of a drug only 18% of the time. Seventy-five percent of these oncologists prescribed infusion drugs and 29% prescribed the expensive, highly-remunerative drug docetaxel.

On October 1, 2006, Alex Berenson reported in the New York Time that worldwide spending on cancer drugs was $24 billion in 2004 and was expected to rise to $55 billion in 2009, “making oncology treatments the biggest drug category,” citing data provided by IMS Health.

In 2005, the government reduced Medicare reimbursement rates for cancer drugs and medications used to counter the side effects of chemotherapy administered in doctors’ offices and cited reports that showed oncologists made $700 million in 2002 from Medicare profits.

“Marketing the Spread” occurs when a drug maker uses the difference between the price paid for a drug by public health care programs like Medicaid and Medicare and the actual cost of the drug charged to doctors or pharmacists as a tool for selling products.

A September 2001 report by the Government Accountability Office cites the list price for one drug used to treat some types of colon cancer at $18.44, with Medicare paying 95% of that cost, while oncologists could purchase it for $2.77.

The GAO also reported that the 86% spread for the cancer drug leucovorin calcium meant that, “Medicare beneficiary’s co-pay alone was actually more than the physician or supplier paid for the drug.”

Before 2005, Medicare paid a markup of 20% to 100% on many injectable drugs, and doctors kept the difference as profit, after certain expenses. The amounts that doctors billed Medicare for injectable drugs rose from $2.9 billion in 1997 to $10.9 billion in 2004.

The Times report shows that doctors were made aware of the amount of money that could be made. Citing documents from a lawsuit filed against Schering-Plough, Johnson & Johnson, AstraZeneca and Bristol-Myers, Mr Berenson reported that the drug companies sometimes “calculated to the penny” how much profit doctors could make and that “sales representatives shared those profit estimates with doctors and their staffs.”

As an example, he quotes a document from 1998 in which Schering-Plough told sales representatives that using the drug Intron-A, for the treatment of bladder cancer, could produce a profit per patient of “$2,373.84 for our physicians just on the drug alone.”

On August 29, 2006, the US attorney for the District of Massachusetts announced that the Schering-Plough Sales Corporation, a subsidiary of Schering-Plough, would pay $435 million to settle criminal and civil allegations relating in part to off-label marketing of drugs, including the oncology drugs, Temodar and Intron A.

Intron A was FDA approved for conditions including chronic hepatitis B, chronic hepatitis C and malignant melanoma. and allegations were made that the Sales Corporation promoted Intron A for treatment of superficial bladder cancer.

Temodar was approved for three specific types of brain cancers, and the Sales Corporation was alleged to have promoted Temodar for treating other types of brain tumors and metastases.

According to the government, pre-tax profits that resulted from the off-label marketing of Temodar and Intron A amounted to $124.2 million. The Sales Corporation agreed to pay a criminal fine of $180 million and was permanently excluded from participation in Medicaid, Medicare and other federal health care programs.

Schering-Plough settled the civil liabilities for losses to public health care programs for a total of $255 million.

In June 2003, AstraZeneca paid $355 million to settle allegations that it marketed the spread and concealed the best price for the prostate cancer drug Zoladex. AstraZeneca pleaded guilty to conspiring to violate the Prescription Drug Marketing Act by supplying free samples of Zoladex to physicians, knowing they would bill Medicare and Medicare beneficiaries a 20% co-pay for the drug.

As part of the plea deal, AstraZeneca agreed to pay a criminal fine of $63.9 million, more than $279 million to settle False Claim liabilities to the US and $11.2 million to the states.

In October 2001, TAP Pharmaceuticals, a joint venture between Abbott Laboratories and Takeda Chemical Industries, paid $875 million to settle charges that it marketed the spread and concealed the best price for the prostate cancer drug Lupron.

TAP pleaded guilty to conspiring to violate the Prescription Drug Marketing Act by giving free samples of Lupron to doctors and allowing them to bill Medicare and Medicare beneficiaries a 20% co-pay for the drug.

TAP paid a $290 million fine to settle the criminal charges, paid the federal government $559.5 million to settle civil liabilities under the FCA and $25.5 million to the 50 states and the District of Columbia to settle the Medicaid fraud liabilities.

On September 20, 2005, the Justice Department announced that GlaxoSmithKline would pay over $150 million to resolve allegations that the company violated the False Claims Act through fraudulent drug pricing and marketing of two anti-emetic drugs, Zofran and Kytril, used primarily in conjunction with oncology and radiation treatment to control nausea and vomiting.

The government also alleged that Glaxo engaged in a “double-dipping” billing scheme by encouraging customers to pool leftover vials of Kytril to create an extra dose, which would then be administered to a patient and re-billed to Medicare and other federal healthcare programs.

Of the $150 million settlement, the federal recovery is approximately $140 million and the states’ recovery for their share of Medicaid is $10 million.

“The Justice Department will continue to pursue these types of fraud schemes vigorously to make clear that we will not tolerate fraudulent pricing practices designed to reap profits for drug companies and doctors at the expense of healthcare programs for the poor and the elderly,” said Assistant Attorney General Peter Keisler of the Justice Department’s Civil Division in the press release.

“As our nation struggles to contain healthcare costs, we must ensure that drug manufacturers do not take advantage of the poor, the elderly or the sick by illegally inflating the price of prescription drugs. That a manufacturer would fraudulently inflate the cost of a drug used primarily to reduce the side effects of cancer treatments is unconscionable,” said US Attorney R Alexander Acosta.

In August 2006, Glaxo paid another $70 million to settle a class action brought on behalf of Medicare beneficiaries who paid some or all of the costs of Zofran and Kytril, along with private insurers and union benefit funds which pay for drugs on behalf of their members, and state Medicaid programs which paid cost-sharing amounts for Medicare beneficiaries.

The 2007 third quarter SEC report filed on November 9, 2007, by Amgen, the maker of Aranesp and Epogen, Erythropoiesis Stimulating Agents, or ESA’s, drugs that were FDA approved to treat anemia caused by chemotherapy and in patients undergoing kidney dialysis, shows that the company is facing massive litigation and government investigations over charges that the company engaged in illegal marketing and promotion in the sale of the ESA’s for uses that were not approved that have now been shown to cause death and serious injuries in patients.

On August 8, 2007, Ironworkers v Amgen, on August 15, 2007, Watters (State of Michigan) v Amgen and on August 28, 2007, Sheet Metal v Amgen, third-party-payor class action lawsuits were filed in the Central District of California.

According to the SEC filing, similar to previously filed third-party-payor class actions, in each action, the plaintiff alleges that Amgen marketed its anemia medicines for “off-label” uses, or uses that are not approved by the FDA, and as a result, the plaintiffs paid for unwarranted prescriptions.

Specifically, the complaints allege that Amgen promoted the drugs for: treating cancer patients who are not on chemotherapy; treating quality of life symptoms associated with anemia, such as fatigue, and reaching Hb targets above the FDA-approved level.

Each plaintiff asserts claims under California’s consumer protection statutes and for breach of implied warranty and unjust enrichment, and plaintiffs seek to represent a nationwide class of individuals and entities.

In Sheet Metal v Amgen, the plaintiff also name privately-owned dialysis centers DaVita and Fresenius as co-defendants and includes a RICO claim. These two dialysis chains reportedly each account for about a third of the market

The SEC filing also notes that two previously disclosed state derivate lawsuits, Larson v Sharer and Anderson v Sharer, were consolidated into one action captioned Larson v. Sharer et al before the Ventura County Superior Court and that a third state derivate lawsuit, Weil v Sharer, was filed on August 13, 2007, in Ventura County Superior Court and was also consolidated with the Larson action.

On August 20, 2007, the class action Harris v Amgen was filed against Amgen and certain of its Board of Directors in the California Central District Court, with claims that the defendants breached their fiduciary duties by failing to inform current and former employees who participated in the Amgen Retirement and Savings Manufacturing Plan and the Amgen Savings Plan of the alleged off-label promotion of both Aranesp and Epogen, “while a number of studies allegedly demonstrated safety concerns in patients using ESA’s.”

On November 2, 2007, the Sheet Metal Workers National Health Fund filed suit in the US District Court for the District of New Jersey against Amgen alleging both federal and state antitrust violations, as well as violations of California’s Unfair Competition Law.

The complaint alleges that Amgen engaged in an “anti-competitive tying arrangement and pricing scheme” involving the sale of three products, Neupogen, Neulasta and Aranesp, and seeks injunctive and compensatory relief for this alleged anticompetitive behavior.

According to the lawsuit, Amgen requires oncology clinics to buy Aranesp, a red blood cell stimulant, if they want better prices for the company’s two white blood cell stimulants, Neulasta and Neupogen, which are both used to combat the side effects of chemotherapy.

The two drugs hold 98% of the market in sales to oncology clinics, Maria Vogel-Short reported in the November 9, 2007, New Jersey Law Journal.

The Sheet Metal Workers Fund is a third-party payer of the costs of Aranesp and the putative class is identified as including anyone who paid all or a portion of the cost for Aranesp at an oncology clinic since April 2004.

The plaintiffs’ attorney, David Cohen, of Saltz Mongeluzzi Barrett & Bendesky in Philadelphia and Voorhees in New Jersey, told Ms Vogel-Short that due to Amgen’s pricing arrangement, clinics are forced to pay higher prices for Aranesp. According to Mr Cohen, Procrit costs $80 to $100 per dose, and Aranesp costs $100 to $300.

The SEC filing also notes that securities class actions, Mendall v Amgen, Jaffe v Amgen, Eldon v Amgen, Rosenfield v Amgen and Public Employees’ Retirement Association of Colorado v Amgen, were consolidated into one action captioned, Connecticut Retirement Plans & Trust Funds v Amgen Inc et al before the US District Court for the Central District of California and that the amended complaint was filed on October 2, 2007.

The filing also lists three third-party-payor class actions including the United Food & Commercial Workers Central Pennsylvania and Regional Health & Welfare Fund v Amgen, the Vista Healthplan Inc v Amgen and the Painters District Council No. 30 Health & Welfare Fund v Amgen, pending in the California Central District Court.

According to the SEC report, Amgen has received a subpoena from the United States Attorney’s Office, Eastern District of New York, for production of documents relating to its products on October 25, 2007, and on November 1, 2007, the company received a subpoena from the United States Attorney’s Office, Western District of Washington, for production of documents relating to its products.

Amgen has also received letters from both the House Subcommittee on Oversight and Investigation, Committee on Energy and Commerce and the United States Senate Committee on Finance, with inquiries related to Amgen’s ESA studies, promotions of ESA and the company’s pharmacovigilance program.

Although Amgen manufactures Epoetin, the company granted a license to a subsidiary of Johnson & Johnson to sell the drug in the US under the trade name Procrit, for treatment of cancer patients but not dialysis patients.

J&J is also facing several class-action lawsuits filed by shareholders, and the company has received a subpoena from New York’s attorney general requesting information on the sales and promotional activities related to Procrit.

A May 10, 2007, article in the Wall Street Journal entitled, “Suit Details How J&J Pushed Sales of Procrit,” by Heather Wontesoriero and Avery Johnson, discusses a lawsuit filed against J&J by Dean McClellan and Mark Duxbury, two former Procrit salesmen turned whistleblowers.

The article sites documents on the marketing of Procrit which show that in 2004, after Amgen’s competing drug Aranesp, billed as a longer acting version of Epoetin, was approved, J&J made offers that would allow buyers of Procrit to receive discounts off an already-reduced price, as well as rebates.

For example, one company memo calculates that a physician who bought nearly $1 million of Procrit over 15 months would get a check for $237,885 back, or 24%.

Another program offered hospitals discounts on purchases from across J&J’s product line “– including some huge-selling drugs and medical devices sold by different subsidiaries — if the hospital used Procrit at least 75% of the time when prescribing anti-anemia drugs.”

Mr McClellan also told the Journal that J&J pushed doctors to administer a higher dose of Procrit for cancer patients beginning in the mid-90’s, many years before a higher dose was approved by the FDA.

Initially, he said in the interview, “doctors weren’t buying into it,” in some cases because doctors were worried that Medicare would not reimburse for the cost of an unapproved dose.

Mr McClellan says he was then told to pitch the regimen as more convenient for patients,to pass out free samples, and that at one time he was given roughly 600 cards for free “trial” samples, worth $720,000 in Procrit, to persuade doctors to try the higher dose.

When an Arizona Cancer Center ran into resistance from Medicare over reimbursing $1 million for the unapproved dose, Mr McClellan told the Journal that a company official drafted a letter, under the name of the center director, to Medicare arguing that the dose was appropriate, and he delivered the letter to the Center for the director to sign.

In 2004, the Center announced that J&J’s Ortho Biotech unit had donated $40,000 to the Center to “provide salary support” for a Hematology/Oncology fellow in a newsletter, the Journal reports.

The article points out that Mr McClellan’s allegations are similar to some of those in other lawsuits and investigations into pricing and marketing practices of top-selling products at other J&J subsidiaries and lists Risperdal, an antipsychotic, Topamax, an anti-seizure drug, and the heart medication Natrecor.

The Journal also notes that in June 2006, the Justice Department issued a subpoena to J&J asking for documents on the marketing of orthopedic devices, the US attorney for the District of New Jersey is leading a probe into kickbacks paid to doctors who use implants sold by J&J subsidiary DePuy Orthopedics, and a congressional committee is looking into marketing practices involving the sale of stents by the Cordis subsidiary.

In November 2007, federal Judge Patti Saris, of the United States District Court in Boston, ordered AstraZeneca to pay double damages totaling $12.9 million and Bristol-Myers Squibb to pay $696,000 for overcharging on cancer drugs, in what legal analysts are calling a test case for a nationwide class action seeking hundreds of millions of dollars from Amgen, Abbot Labs and ten other drug companies.

“I conclude,” she wrote in the order, “that defendants’ conduct was both knowing and willful because they knew that Medicare beneficiaries, and thus their insurers, were locked by statute into paying 20 percent of grossly inflated AWP’s, which bore no relation to any average of wholesale prices in the marketplace.”

Judge Patti Saris found AstraZeneca, Bristol-Myers and Schering-Plough liable for damages in June 2007 for selling drugs to doctors at discounts below the published average wholesale prices and encouraging doctors to bill the government and private insurers full price.

In a June 21, 2007, opinion, Judge Saris wrote: “The Medicare statute itself created a perverse incentive by pegging the nationwide reimbursement for billions of drug transactions a year to a price reported by the pharmaceutical industry, thus putting the proverbial pharmaceutical fox in charge of the reimbursement chicken coop. The different pharmaceutical companies unfairly took advantage of the system by setting sky-high prices with no relation to the marketplace.”

The judge said that AstraZeneca acted “unfairly and deceptively” by causing the publication of false and inflated average wholesale prices for the prostate cancer drug Zoladex, which exceeded doctors’ costs by as much as 169%.

Bristol-Myers caused the publication of false and inflated average wholesale prices for five drugs, including Vepesid, Cytoxan, Blenoxane, Rubex and Taxol, which had spreads as high as 500%, and Schering-Plough inflated average wholesale prices for its generic asthma drug albuterol sulfate in a range of 100% to 800%, Judge Saris said.

A most despicable example of how far the chemotherapy industry will go to protect profits, involves an elaborate plot to stop a new class of immunotherapies from entering the market. These new products stimulate the body’s own immune system to attack only cancer cells.

The profiteering chemo gang’s fear of immunotherapies is not without cause. “One day current treatment approaches such as surgery, radiation and chemotherapy, which often kill most but not all of a cancer, could be made obsolete by a potent immune response that eradicates the cancer cells and provides subsequent protection against return and relapse,” according to former FDA official, Dr Mark Thornton in commentary in the May 14, 2007 Wall Street Journal.

Dendreon was the first company to seek approval for a vaccine called Provenge, for the treatment of men in the final stages of prostate cancer whose only other treatment option is chemotherapy with the drug Taxotere, manufactured by Sanofi-Aventis. In clinical trials, the vaccine was shown to extend the lives of men with prostate cancer for nearly twice as long as chemotherapy.

This particularly egregious act of placing profits over the lives of dying cancer patients has resulted in a lawsuit being filed by outraged members of the prostate cancer community against officials within the Bush Administration who orchestrated a plot to block FDA approval of the vaccine, after an FDA advisory panel voted overwhelmingly to recommend approval.

The main industry insiders listed in this plot include FDA Commissioner Andrew von Eschenbach, the director of the FDA’s Office of Oncology Drug Products, Dr Richard Pazdur, along with Dr Howard Scher from the Memorial Sloan-Kettering Cancer Center, and Dr Maha Hussain from Michigan University.

These four people have made millions of dollars off the chemotherapy industry over the past 2 decades and they will undoubtedly make many more millions once their “public service” ends when the Bush administration finally leaves Washington next year, providing that chemotherapy is not replaced with immunotherapies that is.

The conflicts of interest of these doctors could not be more obvious. The top recipients of public and private cancer research funding in the US include Dr Pazdur’s previous employer of 11 years, the MD Anderson Cancer Center at the University of Texas, Dr Scher’s current employer, the Memorial Sloan-Kettering Cancer Center, and Dr Hussain’s Cancer Center at the University of Michigan.

Prior to his appointment to head the National Cancer Institute in 2001, Dr von Eschenbach, was the executive vice president, chief academic officer and the director of prostate cancer research at the MD Anderson Cancer Center.

A huge number of current clinical trials for late stage prostate cancer patients are lead by Dr Scher and Dr Hussain and involve chemotherapy. Many terminally ill men do not want to risk spending their last days on earth experiencing the debilitating side effects of chemotherapy and if Provenge had been approved finding patients to participate in their clinical trials would have been next to impossible.

Because as noted above by Dr Thornton, these new immunotherapies could potentially end the need for chemotherapy, their approval would also mean the end to the obscene profits made from all the drugs administered to combat the side effects of chemotherapy because the new therapies have no serious side effects.

On the same day that the FDA announced the non-approval of Provenge, the agency also denied the approval of Junovan, to treat children and young adults with non-metastatic osteosarcoma, a rare and often fatal bone tumor. The current treatment is tumor resection with combination chemotherapy before and after surgery. There has not been a new treatment option for this disease in more than 20 years

Junovan stimulates the immune system to kill tumor cells and the clinical trial data showed a significantly increased disease-free survival rate. The probability of surviving without a relapse at 6 years, was 66% for patients who received the drug compared to 57% for patients who did not receive the drug.

According to Dr Thornton, “the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer.”

“The FDA’s hubris,” he wrote, “will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.”

He also noted that the Junovan advisory panel meeting “was chaired by the very physician who launched the PR campaign against Provenge.”

The clinical trials on Provenge were conducted on patients in the last stage of the cancer whose immune systems had already been damaged by radiation and chemotherapy and experts predict that the drugs will work much better with patients in the earlier stages of the disease with healthier immune systems.

The effi�cacy of the vaccine was shown in men who had already failed all conventional therapies. “These advanced stages of cancer are dif�ficult to treat, because the cancer cells have already developed sur�vival mechanisms that make them extremely difficult to eradicate,” according to Dr William Faloon in the article “FDA Rejects Promising Prostate Cancer Drug,” in a special 2007 edition of Life Extension magazine.

“The fact that Provenge� demonstrated such impressive survival benefits in men with these advanced forms of prostate cancer,” he writes, “hints that it could be even more effective if administered in earlier stages of the disease—perhaps at the first sign of metas�tasis or in those men with highly adverse risk factors associated with short survival times.”

Thomas Farrington, president of the Prostate Health Education Network, testified at the FDA advisory committee hearing in March 2007 and recently wrote an editorial on the web site of the Network and stated in part: “I along with all the other survivors and advocates who presented, urged this committee to recommend approval based upon treatment needs and the scientific data from the Provenge clinical trials.”

“We were elated,” he wrote, “when the committee voted 17 to 0 that Provenge was safe and 13 to 4 that it met the FDA’s efficacy standards – an overwhelming recommendation to the FDA for approval.”

“Finally,” he said, “we thought, there would be a treatment for terminally-ill prostate cancer patients without the severe side effects brought on by chemotherapy – the only existing treatment for late stage disease.”

Mr Farrington also noted that Provenge would provide a treatment for the thousands of terminally ill prostate cancer patients unable to endure toxic chemotherapy, like his father who died with no available treatment option.

“In addition,” he wrote, “we envisioned the potential for Provenge to open doors for a whole new class of immunotherapy treatments that could possibly be effective at earlier disease stages while maintaining a better quality of life for patients than today’s treatments.”

“All of these hopes were put on hold when the FDA rejected the recommendation of its own advisory committee,” Mr Farrington pointed out.

Prostate cancer patients say woman should also be demanding an investigation into the corruption within the FDA because due to the non-approval of Provenge, Dendreon has been forced to stop the development of Neuvenge, which uses the same technology platform as Provenge, to treat breast, ovarian and colorectal solid tumors.

According to Mr Thornton, it will be years before the full impact of the FDA’s decisions is known and how many lives of cancer patients are cut short.

“For now, however,” he writes, “one thing is clear: While our lawmakers obsess over FDA “safety reforms,” no one is holding this government agency accountable for its complicity in stalling therapies for life-threatening diseases.”

That day of reckoning may be right around the corner because on December 12, 2007, Congressmen Mike Michaud (D-ME), Dan Burton (R-IN) and Tim Ryan (D-OH) sent a letter to the House Energy and Commerce Committee calling for an examination of the conflict of interests governing the FDA and its failure to approve Provenge, referred to as “a potentially life-saving prostate cancer drug.”

The letter notes that, “there is reason to believe that serious ethics rules were violated,” and “that these violations played a role in the subsequent FDA decision to not approve Provenge at this time.”

“We request your committee conduct a hearing to discuss the FDA’s role in this recent decision and the conflicts of interests in the agency,” the Congressmen wrote.

Cancer Industry Fights To Keep Obscene Profits – Part II

Evelyn Pringle January 2008

Concern about the incentives to overuse injectable cancer drugs, created by the Medicare reimbursement system that paid a markup of 20% to 100%, caused rates to be changed to more closely align with what doctors actually paid for the drugs, and reimbursement is now supposed to amount to only 6% more than the average price paid by all doctors.

In 2005, all totaled, cancer doctors billed about $4.4 billion for chemotherapy and anemia medications, down from $5.6 billion in 2004, and Medicare covered 80% of the bills, according to a report by Alex Berenson in the June 12, 2007, New York Times.

Since the new reimbursement rates went into effect, cancer doctors have been lobbying Medicare officials and lawmakers to raise the prices paid for drugs, and some physicians say that doctors responded to the changes by performing treatments that got them the best reimbursement, regardless of whether the treatment benefited the patients or not.

In general, oncologists make money by providing chemotherapy, even when it has little chance of success. With the new limits on profits, some doctors are performing chemotherapy more often or installing multimillion-dollar imaging machines where they profit when patients receive diagnostic scans, according to the report in the Times.

“There’s pretty good evidence at this point,” Dr Richard Deyo, professor of medicine at the University of Washington and an expert on health care spending, told the Times, “that there are plenty of patients for whom there’s little hope, who are terminally ill, whom chemotherapy is not going to help, who get chemotherapy.”

Dr Robert Geller, an oncologist in private practice from 1996 to 2005, before becoming a senior medical director at Alexion, a biotech company, told the Times that, as long as oncologists continue to be paid by the procedure instead of for spending time with patients, they will find ways to game the system, regardless of how much money they make or lose on prescribing drugs.

“People go where the money is, and you’d like to believe it’s different in medicine, but it’s really no different in medicine,” Dr Geller said. “When you start thinking of oncology as a business, then all these decisions make sense.”

Some doctors are also now requiring cancer patients to make co-payments, which can amount to hundreds of dollars a month. Medicare calls for a 20% co-pay for chemotherapy drugs, but before the reimbursement cuts in 2005, doctors often forgave the co-pays.

In the spring of 2007, reports appeared in the media about cancer doctors receiving rebates of millions of dollars if they purchased bulk supplies of anemia drugs. Doctors were purchasing the drugs directly from Amgen and Johnson & Johnson and then collecting payments from Medicare and private insurers above the price they paid.

The drugs, known as Erythropoiesis Stimulating Agents, or ESA’s, are administered in a doctor’s office. According to the FDA, ESA’s are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy, to reduce need for blood transfusions.

On May 9, 2007, a New York Times article titled, “Doctors Reap Millions for Anemia Drugs,” by Alex Berenson and Andrew Pollack, reported that documents given to the Times showed that at one practice in the Pacific northwest, a group of 6 cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of drugs in 2006.

The FDA-approved labeling for ESA’s says patients should have a hemoglobin level of 10-12 grams per deciliter of blood, and patients are considered to need treatment if their levels fall below 10. Doctors determine whether a patient is anemic and decide on ESA dosing by measuring how much hemoglobin is present in a patient’s red blood cells.

The ESA’s approved for cancer patients are made by Amgen and sell under the brand names Procrit and Aranesp. Although Amgen manufactures Procrit, the firm licenses a Johnson & Johnson subsidiary to sell it.

Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, told United Press International, “Probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs.” A six-month course of treatment per patient can cost more than $10,000.

In November 2006, the FDA issued a public health advisory on all ESA’s, based on a study in the New England Journal of Medicine, which found that patients treated with Procrit, whose hemoglobin levels were raised above the FDA-recommended level, had a higher risk of heart attack, heart failure, stroke or death.

However, in fact, Johnson & Johnson had halted several studies of Procrit in cancer patients in 2003, after they experienced a higher than expected number of blood clots, according to the January 26, 2007, New York Times.

ESA’s are not FDA approved for use with anemic cancer patients who are not undergoing chemotherapy, but doctors have been administering the drugs off-label for that condition. To increase off-label sales, the drug companies used direct-to-consumer advertising to claim that ESA’s could restore energy and reduce fatigue in chemotherapy patients.

However, the FDA says there has never been any evidence to support claims that ESA’s could increase energy or ease fatigue in patients undergoing cancer treatment.

In January 2007, Amgen itself released the results of study conducted in hopes of supporting the approval of Aranesp for use with cancer patients who were not receiving chemotherapy which found that Aranesp did not reduce the need for transfusions and showed an increase in mortality in patients receiving Aranesp by the end of 16 weeks by a statistically significant amount, compared to patients who did not receive the drug.

In March 2007, Representative, John Dingell, (D-MI) chairman of the House Committee on Energy and Commerce, sent letters to Amgen and J&J, saying that the off-label use of the drugs “appear to cause increases in blood clots, seem to grow tumors and are associated with significantly higher mortality rates than placebo,” and told the drug makers to stop all DTC advertising and physician incentives until the FDA determines whether any measures “need to be taken to protect the public from unnecessary risks to human life from these products.”

In March 2007, the FDA added black box warnings to the labels about tumor progression and a decreased survival in patients undergoing cancer treatment. On March 9, 2007, the agency issued a public health advisory to warn doctors treating patients with kidney disease or cancer not to push hemoglobin levels over 12 grams per deciliter of blood.

The FDA again warned that ESA’s were not indicated for anemic cancer patients not undergoing chemotherapy and that mortality was increased when ESA’s were used by this population. The FDA pointed out that ESA’s are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer.

During a March 9, 2007, press briefing, Dr Karen Weiss, deputy director of the Office of Oncology Drug Products, said the FDA became concerned after receiving the results from several trials evaluating the aggressive use of ESA’s to raise hemoglobin levels higher than listed on their approved labels.

In the March 10, 2007, Wall Street Journal, Dr Weiss was quoted as saying, the “bulk of the data that has raised concerns” came when patients were given higher doses, whether they were experiencing anemia from kidney disease or cancer treatment.

The evidence is that “this type of strategy is not beneficial and in fact has some evidence of harm,” she said.

On April 10, 2007, The Wall Street Journal reported that Amgen conducted some studies
which failed to show that the use of Aranesp improved a patient’s quality of life. On May 10, 2007, the Journal reported that J&J had “urged” doctors to enroll patients in “mini” trials using a once-a-week 40,000-unit dose of Procrit instead of three 10,000-unit doses a week.

There were $500 million a year in sales from doctors who prescribed Aranesp “off label” to treat anemia in cancer patients who were no longer receiving chemotherapy, according to the Journal.

On May 10, 2007, the FDA’s Oncology Drug Advisory Panel held a meeting and voted 15-2 in favor of new restrictions for the use of ESA’s, and 17-0 in favor of requiring the drug makers to conduct new clinical trials.

But on May 11, 2007, Bloomberg News reported that the FDA was only given limited access to results from company studies on the drugs. Amgen informed the FDA that the study data requested prior to the meeting of the advisory panel did not belong to the company and because the studies were conducted by third party researchers, Amgen did not have access to the data.

Amgen claimed that attempts were made to obtain the data and informed the FDA that the company would not be able to meet the deadline for submission to the FDA for review prior to the meeting on May 10, 2007.

FDA documents show that three years earlier, at a public meeting of the Advisory Committee on May 4, 2004, Amgen had claimed that 5 studies were being conducted to further investigate the risks of ESA’s in cancer patients, including 4 independent, third-party-sponsored clinical trials.

However, Amgen did not initiate discussions with the independent researchers to obtain the primary data for the studies until several months before the May 2007 advisory panel meeting, according to the FDA.

The FDA wanted the primary data in order to perform its own independent analysis of the results, since the studies were being used by Amgen to address safety issues that were raised by the May 2004 panel.

Concerns over the over-prescribing of ESA’s and the adverse effects on cancer patients prompted the Centers for Medicare and Medicaid Services to review Medicare coverage of their use. On May 14, 2007, CMS released its proposed coverage decision memorandum regarding the clinical conditions for Medicare reimbursement for ESA’s.

CMS found that increased thrombotic-vascular disease, tumor progression, and decreased survival occurred with ESA used to prevent or treat anemia secondary to cancer, cancer chemotherapy, or radiotherapy or to improve tissue hypoxia in an attempt to enhance tumor sensitivity to therapy.

When considering Medicare coverage of ESA’s, CMS opened the issue up for comments, and several commenters noted that it had been difficult if not impossible to obtain access to primary data from ESA clinical trials, making it difficult to conduct an independent analysis of the data.

Dr Marcia Angell, senior lecturer in Social Medicine at Harvard Medical School and former Editor in Chief of the New England Journal of Medicine, expressed concern about the lack of transparency and access of clinical trial data on ESA’s and stated in part:

“Medicare should have access to all the clinical trial information that the FDA has. Currently, companies seeking marketing approval must submit to the FDA all trials, not just the positive ones, but the agency generally does not share this information without the permission of the sponsoring company. That puts the proprietary interests of drug companies ahead of the public interest. Medicare should require full disclosure from the FDA as a condition of its support.”

Many commentators supported non-coverage for treatment of anemia in cancer patients not related to chemotherapy, stating that this was the setting in which much of the adverse outcomes were reported.

According to the CMS report, some beneficiaries with cancer stated that they had received ESA therapy continuously for years, and others stated that they continued to receive ESA’s even after their cancer was in remission.

The agency noted that there was also no evidence to support the off-label use of ESA’s in the treatment of anemia associated with radiotherapy. “The evidence reviewed and the comments received support the determination that ESA’s are not reasonable and necessary for the treatment of anemia associated only with radiotherapy,” the CMS report states.

On July 30, 2007, CMS released a final coverage determination which said that Medicare would cover the drugs for chemotherapy patients only if their hemoglobin levels were less than 10 and coverage would stop if it exceeds that level after 4 weeks of treatment.

In the Decision Memorandum, CMS determined that ESA treatment was not reasonable and necessary for conditions that include: any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis; anemia associated with the treatment of acute and chronic myelogenous leukemias, or erythroid cancers; anemia of cancer not related to cancer treatment; patients with erythropoietin-type resistance due to neutralizing antibodies, and anemia due to cancer treatment if patients have uncontrolled hypertension.

Additionally, CMS will only provide coverage for ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia, if the hemoglobin level immediately prior to initiation or maintenance of ESA therapy is below 10.

Under the old policy, Medicare allowed doctors to get paid even if cancer patients exceeded the recommended hemoglobin levels but normally physicians only transfuse patients when the hemoglobin level approaches or drops below 8, so the use of ESA’s should begin at a level most likely to prevent the hemoglobin from dropping to 8, according to the CMS report.

CMS reiterated the FDA’s warning that ESA’s increased the risk for death and serious cardiovascular events in trials when administered to target hemoglobin greater than 12, as well as an increased risk of serious arterial and venous thromboembolic events, including myocardial infarction, stroke, congestive heart failure and hemodialysis graft occlusion.

In the midst of all the complaining about the reduced coverage rates, on August 31, 2007, Senator Charles Grassley (R-Iowa), ranking member of the Senate Committee on Finance, sent a letter to Amgen CEO Kevin Sharer requesting information on the company’s rebates to health care providers.

The letter notes that the overuse of ESA’s is not only a financial concern, but also a major patient safety concern, given that recent clinical studies have identified increased risks of death, blood clots, strokes, heart attacks and tumor growths when ESA’s are given in higher than recommended doses.

As part of the Committee’s ongoing inquiry into the impact of pricing practices on the utilization of ESA’s, the Senator asked Amgen to provide:

(1) the total, average amounts and range of rebates made to physicians, group practices, physician clinics, hospital outpatient departments, skilled nursing facilities and home health agencies which purchased Aranesp and/or Epogen for calendar years 2004, 2005 and 2006 by state; and,

(2) the number of physicians, group practices, physician clinics, hospital outpatient
departments, skilled nursing facilities and home health agencies in each state which received rebates for Aranesp and Epogen in calendar years 2004, 2005 and 2006.

“As a preliminary response to this request,” the letter instructed, “identify the five physicians, group practices, physician clinics, hospital outpatient departments, skilled nursing facilities and home health agencies that received the highest rebate payments in each state in calendar years 2004, 2005 and 2006.”

Amgen’s latest SEC filing shows that Aranesp sales fell to $460 million for the 3rd quarter of 2007, compared to $720 million in the same period last year, and overall profits are down 82%. On October 17, 2007, Bloomberg News reported that Amgen has lost $18 billion in market value this year.

Not surprisingly, on November 13, 2007, the Wall Street Journal reported that Amgen was pouring millions of dollars into a lobbying campaign in an attempt to get Congress to change the Medicare coverage decision.

“The push,” the Journal says, “underscores Amgen’s dependence on Epogen and Aranesp, which together accounted for 48% of its revenue last year — and the fact that the federal government pays for the biggest share of Epogen.”

Amgen spent $9 million in the first half of 2007, nearly twice the amount that was spent in the previous 6 months. The company has a dozen in-house lobbyists and more than 100 external lobbyists, including former aides to Democratic House Speaker Nancy Pelosi and former Republican Senate Majority Leader Bill Frist, the Journal reports.

California Democrat Representative Pete Stark told the Journal that the integrity of Medicare decisions are at stake. If Congress overturns the new guidelines, the effect would be to tell the “industry they can spend millions of dollars and hire lobbyists all over town to push Congress to overrule sound science,” he warned.

Back on August 17, 2007, Fierce Biotech pointed out that Amgen had racked up $10.2 million in lobbying bills in 2006, “and is now second only to Pfizer in the amount of contributions it makes to federal candidates and parties.”

On November 9, 2007, Pharmalot’s Ed Silverman reported that Amgen was “funding a site called, which was devoted to overturning a recent Medicare decision to reduce reimbursement for Amgen’s big sellers, Aranesp and Epogen,” until November 9, 2007, when it disappeared.

“This website is the online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them needed medicines,” Mr Silverman quoted the site as saying.

“Our goal is to convince the Administration to reverse a recent decision which would effectively deny senior citizen cancer patients’ coverage and access to drugs prescribed by their doctors to combat anemia and reduce transfusions due to strong chemotherapy,” the site said.

According to Mr Silverman, site visitors were instructed on ways to contact their elected representatives and to write testimonials about the anemia drugs.

On November 13, 2007, the Wall Street Journal reported that J&J had launched a similar effort for its anemia-fighting drug, with a website “that allows individuals to send emails to the Center for Medicare and Medicaid Services and contact their representatives in Washington.”

The Journal noted that cancer doctors, “who benefit from Medicare’s unusually high reimbursement rate for anemia drugs, are also in Amgen’s corner.”

On that subject, it should be pointed out that the investigations by lawmakers are conspicuously missing when it comes to all the health care providers who engaged in the over-prescribing schemes for profit involving ESA’s.

The Journal reports that, unlike doctors, all patient groups are not on Amgen’s side. “I am astounded that this has been reduced to, ‘We want to protect patients,’ ” Frances Visco, president of the National Breast Cancer Coalition and a 20-year cancer survivor, told the Journal.

Ms Visco says the campaign has confused cancer patients who “feel used by this,” and she has urged Congress to reject what she calls Amgen’s “abusive” efforts. “Amgen is primarily interested in protecting Amgen,” she said in the Journal article.

All that said, the millions of dollars spent on lobbying and political contributions should not have any effect on the decision to limit coverage for ESA’s because new studies with reports of adverse effects in cancer patients using the drugs continue unabated. On November 8, 2007, the FDA announced new boxed warnings and labeling changes for ESA’s with statements about the risks that the drugs pose to patients with cancer.

In a press release, the FDA once again notes that ESA’s are approved to treat anemia caused by chemotherapy and says the new boxed warning clarifies that ESA’s should only be used when treating anemia specifically caused by chemotherapy and that ESA’s should be discontinued once the patient’s chemotherapy course has been completed.

The FDA repeats that an earlier boxed warning in March 2007 described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESA’s were used to achieve hemoglobin levels of 12 or greater in cancer patients.

For patients with cancer, the new warnings advises that ESA’s caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 or greater.

The warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a level of less than 12, the hemoglobin level commonly achieved in clinical practice.

“Health care professionals need to consider the risks of increased tumor progression and decreased survival in patients with cancer when prescribing ESA’s,” said Janet Woodcock, the FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director of its Center for Drug Evaluation and Research, in a press release.

On January 3, 2008, the FDA announced that the agency was reviewing more new data from two studies that provide further evidence of the risks of anemia drugs and show that patients with breast or advanced cervical cancers who received ESA’s to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who did not receive the drug.

The agency notes that these studies were not among the 6 that were described in revised labeling on November 8, 2007. Taken together, all 8 studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESA’s, compared to patients who did not receive the treatment, according to the agency.

In its November 9, 2007, third quarter SEC filing, Amgen explains fairly clearly why the company is so worried about the Medicare coverage decision, in stating:

“The Decision Memorandum establishes the ESA reimbursement policy for Medicare and other government beneficiaries who are treated for CIA and who all together accounted for approximately 50% of the U.S. cancer patients receiving Aranesp prior to its issuance.”